Comparison of [68Ga]Ga-CTR-FAPI and 18F-FDG PET/MRI for Lymph Node Staging in Rectal Cancer (NCT07552207) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of [68Ga]Ga-CTR-FAPI and 18F-FDG PET/MRI for Lymph Node Staging in Rectal Cancer
30 participantsStarted 2026-04-01
Plain-language summary
This is a prospective, single-center, diagnostic study designed to compare the accuracy of \[68Ga\]Ga-CTR-FAPI PET/MRI and \[18\]F-FDG PET/MRI for the detection of lymph node metastasis in patients with initially untreated, resectable middle to high rectal cancer. The study aims to evaluate whether \[68Ga\]Ga-CTR-FAPI PET/MRI provides higher sensitivity and specificity than traditional 18F-FDG PET/MRI at both the patient level and the lymph node level.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Confirmed rectal adenocarcinoma by pathological biopsy.
* Lower margin of the tumor is ≥ 5 cm and ≤15 cm from the anal verge.
* Planned to undergo radical surgery.
* ECOG performance status score ≤ 2.
* Patient is willing to undergo PET/MRI examination.
Exclusion Criteria:
* History of pelvic radiotherapy or chemotherapy.
* Concurrent with other malignant tumors or active infections.
* Pregnant or unable to sign the informed consent form.
* Claustrophobia or inability to tolerate MRI examinations due to other reasons.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity and Specificity of Lymph Node Metastasis Detection
Timeframe: Up to 30 days post-surgery
Trial details
NCT IDNCT07552207
SponsorPeking University Cancer Hospital & Institute